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Homocysteine quality control material
EUDAMEDClass IVD General (EU MDR)
Ref REF: USCA00000764、USCA00000790-USCA00000797
Identity
- Device Name
- Homocysteine quality control material EUDAMED
- Model / Reference
- REF: USCA00000764、USCA00000790-USCA00000797 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6-138FR EUDAMED
- Basic UDI-DI
- B-6-138FR EUDAMED
- EMDN Code
- W0101050299 SPECIFIC CONTROLS (CC) - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Homocysteine quality control material by URIT Medical Electronic Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-6-138FR | Class IVD General | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 1cc3de75-4936-4f74-ab07-4a2b05aa55e2 61 fields · synced Oct 6, 2026